Clinical Management of Antiplatelet Drug Resistance in Patients With Drug Eluting Coronary Stents

Phase 4

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: Plavix (Clopidogrel)

• Registration Number: NCT00589862
• Lead Sponsor: Creighton University

Brief Summary

It is recommended that patients who have drug-eluting stents placed in their coronary arteries take aspirin and Plavix (Clopidogrel) for at least a year. Patients who stop taking these antiplatelet drugs or who have resistance to the antiplatelet effects of these drugs are at a higher risk of clots occurring inside the stents which may result in a heart attack. At the present time, it is unknown if increasing the doses of the antiplatelet agents is effective in overcoming this resistance. The purpose of this project is to identify patients with antiplatelet drug resistance and to test whether an increase in the Plavix (Clopidogrel) dose overcomes antiplatelet drug resistance.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Required Coronary Artery Angioplasty with a drug-eluting stent deployment

Exclusion Criteria

• The last drug-eluting stent placed greater than 2 weeks prior
• Aspirin or Plavix (Clopidogrel) allergy or contraindication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Plavix (Clopidogrel)	-

Primary Outcome Measures

Name	Time	Method
to evaluate the frequency of aspirin and Plavix (Clopidogrel) resistance (as measured by a percent inhibition of platelet aggregation) in patients undergoing coronary drug-eluting stent deployment	3 month intervals up to 12 months

Secondary Outcome Measures

Name	Time	Method
to assess if a Plavix (Clopidogrel) dose increase in patients with resistance to both aspirin and Plavix (Clopidogrel) is effective in overcoming antiplatelet drug resistance	3 month intervals up to 12 months
to evaluate the frequency of major adverse cardiovascular events in patients with and without antiplatelet resistance and following a dose increase in Plavix (Clopidogrel).	3 month intervals up to 12 months

Trial Locations

Locations (1)

Creighton University Medical Center; 🇺🇸 Omaha, Nebraska, United States